Implication of Metabolic and Genomic Modifications in Elderly Subjects
COMPALICLAMP
1 other identifier
interventional
35
1 country
1
Brief Summary
An increase of longevity and of the number of men and women older than 60 years old is observed in most industrialized countries. Aging is a complex, multifactorial and continuous process involving physical and biological modifications such as a notably decrease in glucose tolerance and type 2 diabetes risk. Insulin sensitivity follow-up during aging is difficult mainly because of many confounding factors (environment, lifestyle). In 2006, SUVIMAX 2 study began, based on the monitoring of volunteers who participated in former SUVIMAX study (1994-2003). This study was a randomised trial which was designed to study the link between a low antioxidant intake and risk of cancer or ischemic heart disease. The subjects recently had a health check-up including complete information about their diet, physical and neurosensory status. Based on these data, a score was established to classify subjects according to their quality of aging ("successful aging versus "problematic aging") These volunteers, who undertook a 13-year follow-up (dietary and medical status), constitute the reference population to determine the mechanisms involved in the insulin resistance development in aging. The purpose of our research work is to determine whether the quality of aging could influence insulin sensitivity, by studying metabolic profile and change in gene expression (genes involved in glucose metabolism and metabolic senescence in muscle tissue) during aging.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2009
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 31, 2009
CompletedFirst Posted
Study publicly available on registry
August 4, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedMay 28, 2019
March 1, 2010
6 months
July 31, 2009
May 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of metabolic profile (lipid metabolism and energy expenditure) and insulin sensitivity based on the aging quality
120 minutes
Secondary Outcomes (2)
Gene expression in muscle tissue by quantitative RT-PCR: genes involved in the carbohydrates and lipids metabolism (lipid carriers, PPARs), 7 sirtuins isoforms and of their target genes (NFkB, PGC1a)
one day
Gene expression in muscle tissue by Global transcriptome analysis by DNA Chip
one day
Study Arms (2)
Problematic aging
EXPERIMENTALsuccessful aging
EXPERIMENTALInterventions
Insulin perfusion at 1 mU.kg-1.min-1 Glucose perfusion to maintain euglycemia at 5,0 ± 0,5 mmol/l Blood tests
Gene expression in muscle tissue will be studied with two approaches : * Candidate gene approach by quantitative RT-PCR : genes involved in the carbohydrates and lipids metabolism including lipid oxidation in muscle (lipid carriers, PPARs), expression of 7 sirtuins isoforms as well as some of their target genes (NFkB, PGC1a) * Global transcriptome analysis by DNA Chip
Eligibility Criteria
You may qualify if:
- Volunteers from the cohort aging SUVIMAX 2
- Men and Women
- over 60 years
- BMI between 18 and 35 kg/m2 (including terminals)
- Normal medical check up
- Blood pressure \< 140/90 mmHg
- Normal glycemia, lipid profile
- sedentary or moderate physical activity (maximum 4 hours per week)
You may not qualify if:
- Biological results or anormal chek-up
- medical or surgical history not compatible with study
- severe digestive, cardiovascular, renal, liver or tumor disorders history in the 5 last years
- infectious or inflammatory disease within 2 months
- surgical history within 3 months
- bood donation within 2 months
- coagulation disease, anticoagulant or antiplatelet agents (aspirin ...) treatment
- xylocaïn allergy
- claustrophobia
- Drug that could affect insulin sensitivity (beta blockers, lipid lowering, oral antidiabetics, insulin, , steroids)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre de recherche en nutrition humaine Rhône-Alpes
Pierre-Bénite, 69495, France
Related Publications (1)
Betry C, Meugnier E, Pflieger M, Grenet G, Hercberg S, Galan P, Kesse-Guyot E, Vidal H, Laville M. High expression of CPT1b in skeletal muscle in metabolically healthy older subjects. Diabetes Metab. 2019 Apr;45(2):152-159. doi: 10.1016/j.diabet.2018.01.018. Epub 2018 Feb 12.
PMID: 29657112RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martine LAVILLE, MD, PhD
Centre de Recherche en Nutrition Humaine Rhône-Alpes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 31, 2009
First Posted
August 4, 2009
Study Start
May 1, 2009
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
May 28, 2019
Record last verified: 2010-03